Device evidence

device-recall:cfres:188895

uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

Official recall number

Z-2593-2021

Evidence summary

Product code: KPS
Recall status: Open, Classified
Event initiated: August 02, 2021
Root cause: Device Design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-2593-2021